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. 2023 Sep 8;2023(9):CD014805. doi: 10.1002/14651858.CD014805.pub2

ChiCTR1800019501.

Study name A randomized controlled phase II clinical trial comparing neoadjuvant TP (docetaxel + cisplatin) with TAC (docetaxel + adriamycin + cyclophosphamide) regimen in the treatment of operable triple negative breast cancer
Methods Accrual: recruiting
Accrual target: 212 participants
Single‐centre, phase 2 RCT
Trial is being conducted in China
Blinding: not specified
Participants Clinical T2‐T4c or T1C with axillary lymph node‐positive
Neoadjuvant setting
Interventions Arm 1: intervention: docetaxel and cisplatin for 6 cycles
Arm 2: comparator: docetaxel, doxorubicin and cyclophosphamide for 6 cycles
Outcomes Primary
  • Pathological complete response rate


Secondary
  • Safety

  • Disease‐free survival

  • Rate of breast‐conserving surgery

  • Clinical response rate

  • ypT0ypN0, ypT0/is ypN+, ypT1mic ypN0/+

Starting date Planned start date: 1 December 2018
Estimated completion date: 31 May 2025
Contact information Contact: Liu Zhenzhen (liuzhenzhen73@163.com)
Notes Trial registration link: www.chictr.org.cn/showprojEN.html?proj=31567
Trial sponsor: He'nan Cancer Hospital
Funding considerations: self‐funded